A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars

Официальное название

A Multicenter, Cohort-design, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars

Обзор

Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal healing process for acne. Acne scarring that remains after acne resolves has a significant impact on health related quality of life, including reduced self-esteem and embarrassment/self consciousness. ELAPR002f provides an immediate space-occupying effect for filling in the scar tissue. The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars. ELAPR002f injectable gel is an investigational device being developed for the treatment of facial atrophic acne scars. There are 2 cohorts in this study. In Cohort 1, all participants will receive ELAPR002f injectable gel. In Cohort 2, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to the saline active control group. Around 395 adult participants with moderate to severe atrophic acne scarring on both cheeks will be screened in the study in approximately 25 sites in the United States. Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control and will be followed for up to an additional 12 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Устройство ELAPR002f Injectable Gel
  Intradermal Injections
• Устройство Saline Control
  Intradermal Injections

Первичные конечные точки

• Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area [Срок оценки: Baseline to Day 181]
• Number of Participants with Adverse Events [Срок оценки: Up to Day 420]
• Number of Participants with Presence of Binding Antibodies [Срок оценки: Up to Day 420]
• Number of Participants with Injection Site Responses (ISRs) and Systemic Responses [Срок оценки: Up to Day 420]
• Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters [Срок оценки: Up to Day 420]
• Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters [Срок оценки: Up to Day 420]
• Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements [Срок оценки: Up to Day 420]
• Change from Baseline Procedure Pain [Срок оценки: Up to Day 420]
• Number of Participants with a Positive Skin Test [Срок оценки: Up to Day 420]
• Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion [Срок оценки: Up to Day 420]

Вторичные конечные точки (7)

• Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire [Срок оценки: Up to Day 420]
• Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress [Срок оценки: Up to Day 420]
• Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Total Score [Срок оценки: Up to Day 420]
• Percentage of Participants Achieving "Responder" Status on Either Cheek Based on the Allergan Acne Scar Improvement Scale (ASIS), as assessed by the Evaluating Investigator [Срок оценки: Up to Day 420]
• Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area [Срок оценки: Up to Day 420]
• Percent Change from Baseline in Acne Scar Area [Срок оценки: Up to Day 420]
• Percent Change from Baseline in Acne Scar Volume [Срок оценки: Up to Day 420]

Критерии участия

Критерии включения

• Participants in general good health, and seeking improvement of atrophic acne scars.
• Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan Acne Scar Improvement Scale \[ASIS\]) on each cheek based on evaluating investigator (EI) live assessment (both cheeks must qualify but do not need to have the same score) at the first Screening Visit.
• At least 5 rolling or boxcar-type acne scars in total within the predefined 4 cm × 4 cm assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator (TI).

Критерии исключения

• The participant has clinically significant acne on the face.
• Current cutaneous or mucosal inflammatory or infectious processes other than acne (eg, herpes), rosacea, abscess, an unhealed wound, or a cancerous or precancerous lesion, on the face.
• The participant presents with predominantly ice pick scars.
• History of keloid scar formation, hypertrophic scarring, and/or post inflammatory hyperpigmentation or hypopigmentation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 10 центров

• Advanced Research Associates - Glendale /ID# 254961 — Glendale
• Marcus Facial Plastic Surgery /ID# 275880 — Redondo Beach
• Pacific Clinical Innovations /ID# 256185 — Vista
• DMR Research PLLC /ID# 256199 — Westport
• Hamilton Research, LLC /ID# 256925 — Alpharetta
• Aesthetic Center at Woodholme /ID# 256197 — Baltimore
• The Center for Dermatology Cosmetics & Laser Surgery /ID# 256182 — Mount Kisco
• Wilmington Dermatology Center /ID# 256192 — Wilmington
• … и ещё 2 центра

Идентификаторы

NCT: NCT07207369 · 2015-701-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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